NCT00758277

Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.

Detailed description

Out-patients with alcohol dependence recently detoxified Primary goal size is the duration of the Abstinenz up to the heavy relapse. Secondary objective size are: * Frequency of Lapses * Time up to the first alcohol drinking * cumulative times of do not drink * Craving * Alcohol drinking quantity * Sleep quality * Tolerability/Bearableness of the study medication * Security * Drop Out rate * Side effects * Changes with the neuropsychological testing HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, TLFB, SCL-90. * Quality of life

Conditions

• Alcohol Dependence
• Alcoholic Relapse

Interventions

Type	Name	Description
DRUG	levetiracetam (Keppra)	levetiracetam daily application 1500-2000 mg
DRUG	Placebo	Sugar Pill

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-07-01
• Completion: 2009-12-01
• First posted: 2008-09-25
• Last updated: 2011-06-23

Locations

11 sites across 1 country: Germany